Remote Principal Biostatistician for Cardiovascular Trials

Edwards Lifesciences; Richmond (VA); Sur place; USD 132 000 - 186 000; Plein temps

Résumé du poste

Edwards Lifesciences is seeking an experienced Principal Biostatistician to lead statistical analyses for clinical programs in the Transcatheter Mitral and Tricuspid Therapies unit. You will guide trial analyses, support regulatory submissions, and mentor junior staff in a data‑driven environment.

The role requires a Ph.D. in Statistics/Biostatistics with post‑graduate experience in clinical trials, regulatory standards, and strong communication skills.

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience
• Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years’ experience

Responsabilités

• Statistical lead on multiple clinical trials, coordinate analyses for study reports and provide programming/validation support
• Collaborate with stakeholders to support NPD/regulatory submissions (PMA, CE Mark, PMDA) and other documents
• Represent Biostatistics on project teams and communicate status and timelines
• Research and recommend novel statistical methodologies and approaches
• Provide statistical guidance on ad hoc analyses and publications
• Prepare technical documents for audits and SOPs/WIMs

Connaissances

R

Statistical leadership

Communication

Problem solving

Formation

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Outils

R

S-PLUS

CDISC (SDTM/ADaM)

MS Office (Word/Excel/PowerPoint)

Description du poste

Edwards Lifesciences is seeking an experienced Principal Biostatistician to lead statistical analyses for clinical programs in the Transcatheter Mitral and Tricuspid Therapies unit. You will guide trial analyses, support regulatory submissions, and mentor junior staff in a data‑driven environment.

The role requires a Ph.D. in Statistics/Biostatistics with post‑graduate experience in clinical trials, regulatory standards, and strong communication skills.